Frequently asked questions
Regulation governance and safety
Compliance, cyber security and classification
GETTING STARTED
The Pharma Printer is made for hospital and retail pharmacies, including at point of sale. It is also designed for the pharma industry and veterinarians.
From our webstore or via contacting sales.
You can order GMP manufactured Excipient Bases from our webstore or via contacting sales.
The delivery time is approx 6-8 weeks, depending on order volume.
Our technology is effective for both human and veterinary medicine.
Yes, this is possible from our webstore or via contacting sales.
Our solution is easy to use and it takes only an hour to learn the Pharma Printer and quality control tools
We offer several pricing options, including purchase, rental, or a model based on a minimum order of Excipient Bases. There is no charge for formulation development. Instead, customers may subscribe to our formulation library.
Would you like a quote? Please contact us, and we are happy to help you forward.
Typically, we perform a IQ/OQ of the Pharma Printer with the customer. The technology is ready to use after this and training.
MANUFACTURING
It takes 1-3 seconds to print one dose.
It is possible to flexibly print several dozen tablets at one time, depending on the size of the tablets. On average, 1000 doses can be printed in an hour with quality control. In some instances, printing may be faster.
We provide validated cleaning protocols for each formulation and single-use syringes to avoid cross-contamination. All parts are easy to clean, and it typically takes less than 10 minutes to complete between different APIs.
Yes, it is possible to dose into blisters, molds or vials.
We provide templates for unit dosing or pharmacies can use their own.
Use the Compounding System Solution to dose chewable tablets, suppositories, or liquids - all with one device and without changing the extruder. You can dose API’s ready to be used with our Excipient Bases or your own. We provide a formulation library of more than 200 API’s that our customers are compounding today.
These include stability data and dissolution profiles.
Please contact us. for a list of our current APIs .
We have an integrated analytical scale to measure individual weights of the dosage forms and in-process NIR control to evaluate the blend uniformity of the Pharma Inks prepared at the pharmacy. Documentation and batch record is available in our formulation library.
Yes, the CuraBlend has a PZN number which is 19290012.
REGULATION, GOVERNANCE AND SAFETY
CurifyLabs is compliant with existing regulations for pharmacy compounding. We provide the following:
- Our quality management system is compliant with ISO 13485
- CE marked for IEC 61010-1 (classified as laboratory equipment)
- We provide quality documentation for printable pharma ink bases which can be used with several API’s. As our customer you have access to all necessary quality documentation (stability, dissolution, batch records, cleaning protocols etc)
- All raw materials are compliant with the European pharmacopeia.
- Excipient Bases are GMP manufactured and classified as medicinal intermediate product.
- We offer in-process quality control of mass and blend uniformity.
Pharma Printer cannot be accessed directly from the Internet. CurifyLabs also recommends installation behind a company firewall.
CurifyLabs’ Web App is regularly subjected to 3rd party cybersecurity testing.
Pharma Printer does not process or store patient data. In instances where we require an email address, we store that address in a GDPR complaint manner.
Pharma Printer is not a medical device. It is a laboratory equipment comparable to, for example, HPLC.
GENERAL
Pharma Printer requires cable (LAN) connection to access the Internet.
The Pharma Printer has a simple-to-use interface designed for busy pharmacies. We offer additional research features for customers who require it.
Pharma Printer is designed and manufactured in European Union.
We share information about the bases in our customer portal. Pediatric formulations are compliant with pediatric patient safety recommendations.
Yes. To ensure the best dosing experience and utilize our extensive formulation library and Excipient Bases, we recommend using inks that we have been validated with the Compounding System Solution. These also include stability data, dissolution profiles, and other required documentation for regulators.
Our Excipient Bases are based on over a decade of academic research and built by over 50 pharmacists.
We offer 3 service plans for your convenience.